What is the CorWave LVAS studying for advanced heart failure?

The CorWave LVAS study is evaluating the safety and effectiveness of a new heart pump device for patients with advanced heart failure. Researchers want to see how well the device supports heart function and improves survival while monitoring for any device-related complications. The study is sponsored by CorWave and aims to provide information on this treatment option.

Who may be eligible for this advanced heart failure clinical trial?

Adults aged 18 to 75 years with advanced heart failure and low heart pumping function may be eligible. Participants must have a body surface area of at least 1.2 m2 and be eligible for heart transplantation. They also need to meet specific heart function criteria related to inotrope use or cardiac index. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced heart failure clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 75Years

All Genders

ID06907017

First Human Study of the CorWave Left Ventricular Assist System to Treat Advanced Heart Failure in Adults

Led by CorWave · Updated on 2026-08-03

Participants Needed

Research Sites

91 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the CorWave Left Ventricular Assist System LVAS for treating patients with advanced heart failure. This prospective, multi-center, non-randomized trial focuses on adults aged 18 to 75 years who have advanced left ventricular heart failure and meet specific heart function criteria. The study is sponsored by CorWave and aims to assess survival and freedom from adverse events related to the device. Participants will receive implantation of the CorWave LVAS device to support heart function. The study follows a single group design where all participants receive this advanced device to treat their condition. The treatment period includes monitoring for survival and device-related complications, with outcome measurements extending up to two years after implantation. During the study, participants undergo regular assessments including evaluations of survival 30 days post-implant, adverse events, quality of life, neurocognitive function, and functional status up to two years. Researchers will also track freedom from bleeding, infection, stroke, and other complications at various time points. The total participation duration spans up to two years with ongoing safety and health monitoring throughout the study.

CONDITIONS

Brief Title

CorWave LVAS FIH Study

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Subject or legal representative has signed Informed Consent Form
Age over 18 and under 75 years old
Body Surface Area (BSA) at least 1.2 m2
Left Ventricular Ejection Fraction (LVEF) 35% or less
Inotrope dependent OR
Cardiac Index (CI) below 2.2 L/min/m2 while not on inotropes and must also meet one of the following:
- On Guideline Directed Medical Therapy (GDMT) for at least 45 of the last 60 days and failing to respond
- Advanced heart failure (Class III or IV for at least 14 days with short term mechanical support up to 7 days)
Females of childbearing age must agree to use adequate contraception
Patient must be eligible for heart transplantation

You will not qualify if you...

Heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
Technical obstacles posing high surgical risk as judged by investigator
Ongoing mechanical circulatory support other than IABP or micro axial pumps
INTERMACS Class I patients
On a ventilator
Pregnant or breastfeeding
Presence of mechanical aortic valve not converted to bioprosthesis at LVAD implant
History of any organ transplant
Platelet count below 100,000/µl
Psychiatric disease, illicit drug use, irreversible cognitive dysfunction or psychosocial issues impairing compliance
History of untreated abdominal aortic aneurysm over 5 cm diameter within 6 months
Active, uncontrolled infection
Intolerance to required anticoagulant or antiplatelet therapies
Severe end organ dysfunction or failure risk factors including:
- INR 2.0 or higher not due to anticoagulation therapy
- Total bilirubin over 43 µmol/L (2.5 mg/dL), liver tests > 3 times normal, serum albumin below 3.5 g/dl, shock liver, or liver cirrhosis
- Severe COPD and restrictive disease with FEV1 below 50%, total FEV1 under 1000 mL, DLCO below 50% predicted
Fixed pulmonary hypertension with PVR 8 Wood units or higher unresponsive to treatment
Stroke within 90 days or significant carotid stenosis over 50%
Serum creatinine 221 µmol/L (2.5 mg/dL) or higher or need for chronic renal replacement therapy
Malnutrition with weight loss over 5% in 30 days, prealbumin below 16 mg/dL, or low Mini Nutritional Assessment score
Poorly controlled diabetes or hemoglobin A1c over 8.5%
Significant peripheral vascular disease with rest pain or ulcers
Severe aortic insufficiency without correction plans during implant
Planned Bi-VAD support before enrollment
Known hypo or hyper coagulable states
Participation in other clinical investigations that may affect study results
Any condition limiting survival to less than 12 months besides heart failure
Acute myocardial infarction within 14 days of implant
Pulmonary embolus within 6 weeks of implant
Unwilling or unable to comply with trial requirements

Research Team

Gabriella Giaquinta

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First Human Study of the CorWave Left Ventricular Assist System to Treat Advanced Heart Failure in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria